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Completed

NCT Number: NCT03340922

MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation

Current navigation systems incorporate algorithms for automatic identification of local activation time (LAT). However, data about their utility and accuracy in premature ventricular complex (PVC) ablation procedures are scarce. This prospective, randomized study analyzes the accuracy and effectivity of an algorithmic method based on automatic annotation of the maximal negative slope of the unipolar electrogram within the window demarcated by the bipolar electrogram, compared with conventional, manual annotation during PVC ablation procedures.

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Key information

Conditions

Ventricular Premature Complexes Arrhythmias, Cardiac Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Catheter Ablation Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Antonio Berruezo, MD, PhD

Barcelona, 08022, Spain

About this study

This is a prospective, randomized, controlled and international multicenter study. The investigators aim to analyze the accuracy of LAT annotation using a novel algorithmic method (Wavefront, CARTO, Biosense Webster, Diamond Bar, California, USA) (WF), based on automatic annotation of the maximal negative slope of the unipolar electrogram (U-EGM) within the window demarcated by the B-EGM, by comparison with conventional, manual annotation in a multicenter cohort of patients referred for PVC ablation. Further on, the automatic annotation of LAT will be aided by an ECG recognition pattern algorithm (included in the last version of CARTO), which is intended to avoid wrong annotation of ventricular complexes other than the clinical PVC. The investigators hypothesize that automatic LAT annotation (using WF and the ECG recognition algorithm) could be superior to conventional, manual annotation in terms of mapping success and could reduce both procedure time and radiofrequency time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years.
  • Indication for PVC ablation.
  • Signed informed consent.

Exclusion criteria

  • Age < 18 years.
  • Pregnancy.
  • PVC ablation procedures guided by pace-mapping (PASO® module); eg. low burden of PVCs during the study, mechanical impact during activation mapping.
  • Impossibility to perform activation mapping with the required density of points in the region of interest (see section 4.5.3).
  • Concomitant investigation treatments.
  • Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Treatment and study plan

Automatic annotation of LAT (WF-method)

Device

Automatic annotation of LAT during PVC activation mapping. Acquisition of points will be automatically performed using the Wavefront (WF) annotation tool integrated into CARTO navigation system.

Other names: Wavefront

Manual annotation of LAT (M-method)

Device

Conventional, manual annotation of LAT during PVC activation mapping. Acquisition of points will be performed using the CARTO navigation system by an expert electrophysiologist.

Other names: Manual

Primary outcomes

  1. Rates of mapping success, using the assigned mapping approach (automatic vs. manual), as defined in description

    Time frame: 12 months

    Mapping success will be defined as complete PVC abolition after RF applications at the earliest activation site (EAS) identified using the assigned mapping approach. A maximum of 2 RF applications with appropriate parameters (contact force, impedance drop, catheter stability) during a maximum of 45 seconds will be allowed. If the PVC is not abolished after 2 RF applications with appropriate parameters, mapping will not be considered successful.

Secondary outcomes

  1. Mapping time

    Time frame: 12 months

  2. Number of mapped chambers

    Time frame: 12 months

  3. Accuracy of a proposed algorithm for selection of first chamber to map

    Time frame: 12 months

    In the case of PVCs arising from ventricular outflow tracts, we propose an algorithm to avoid subjective criteria, and to deal with eventual wrong selection of the first mapped chamber, leading to unnecessary RF applications. This algorithm involves a step-by-step analysis of the PVC-ECG morphology: precordial R/S transition and presence of one or more of the following clinical items, which have been previously related with a left origin: male gender, hypertension, or age > 50 years.

  4. Number of target points

    Time frame: 12 months

    Target point is defined as any suspected PVC-site of origin where RF is delivered according to mapping data. Therefore, for one case there can be found a single target point with multiple RF applications, or multiple target points with one single RF application. The maximum distance between 2 RF applications to be considered at the same target point will be defined as 5 mm (equivalent to a 1-cm2 area).

  5. Radiofrequency (RF) time

    Time frame: 12 months

  6. Number of RF applications

    Time frame: 12 months

  7. Acute procedure success

    Time frame: 12 months

    Complete elimination of the PVC at the end of the procedure.

  8. Clinical success

    Time frame: 1 month

    Reduction of, at least, 80% in the 24-hour PVC burden 1 month after the procedure.

Sponsors and collaborators

Lead sponsor

Centro Medico Teknon

Other

Registry information

Official study title

MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation Procedures (MANIaC-PVC Study). A Randomized, Multicenter Study

Acronym: MANIaC-PVC

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 14, 2017
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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